Principle Regulatory CMC Consultant

An exceptional opportunity awaits with our client, a dynamic Regulatory Affairs Consultancy with a presence in the UK, Switzerland, and Ireland, serving global clients. In this role, you will join a team of seasoned experts in Regulatory, CMC, Clinical, and Non-Clinical fields, leveraging your CMC and Regulatory expertise to provide comprehensive support and guidance to clients throughout the product development lifecycle.
The ideal candidate will have a proven track record of delivering top-notch regulatory advice and support to both internal and external stakeholders. Experience with innovative biological products is essential, and a background in vaccines, ATMPs, or previous experience with FDA/EMA/National regulatory authorities is highly desirable. The successful candidate will possess a solution-oriented mindset, a proactive attitude, and the ability to think creatively to achieve optimal outcomes for clients and products.
Qualifications (Senior Consultant)
A minimum of a Master’s degree; PhD or Pharmacy degree preferred.
At least 3-5 years of regulatory experience in the industry, with significant experience with EU and US Regulatory Authorities strongly preferred.
Fluency in English is required; proficiency in an additional European language is an asset.
Excellent written and verbal communication skills.
Advanced analytical thinking with a solution-focused approach.
Collaborative and forward-thinking attitude.
Proven consulting skills desirable (training available).
Advanced Microsoft IT skills (training available). Previous experience with industry document management systems is highly desirable.
Responsibilities (Senior Consultant)
Provide CMC advice and support on client engagements for both biological and small molecules, including innovative and first-in-class products.
Support CMC regulatory activities such as dossier authoring (IND/IMPD, MAA/NDA Module 3), preparation of Scientific Advice briefing documents, and responses to Requests for Information. Lifecycle maintenance activities.
Gather and process data, collaborating with technical functions within client organizations to generate necessary submission documents.
Offer regulatory and strategic advice to address issues raised by Regulatory Authorities.
Prioritize tasks effectively, remaining agile and responsive to changing and conflicting priorities.
Deliver high-quality work that exceeds client expectations.
Proactively seek opportunities to develop and enhance professional skills.
Take initiative and actively seek out solutions aligned with client business needs.
Contribute to thought leadership activities, including attending conferences, authoring journal and website articles, and expanding the client database.
Qualifications (Principal Consultant)
All qualifications of a Senior Consultant, with at least 10-15 years of industry experience, including time spent within a National Competent Authority, FDA, or EMA.
Proven business development skills with a track record of creating or developing client relationships.
Experience advising senior leadership within client organizations (e.g., CEO, CSO, COO).
Strong understanding of the challenges faced by smaller biotech companies in early development (Proof of Concept to Phase 2).
Ability to tailor advice to client constraints, navigating regulatory requirements to streamline development activities.
Willingness to travel within Europe occasionally ( Responsibilities (Principal Consultant)
All responsibilities of a Senior Consultant, plus:
Take an active role in business growth by creating, leading, and managing client relationships.
Lead and manage multi-functional (Clinical, Non-Clinical, CMC, Regulatory) Subject Matter Expert teams to deliver client engagements.
Lead CMC development activities on behalf of clients, integrating seamlessly into their teams to deliver CMC programs in collaboration with clients, CROs, and CDMOs.
Conduct technical due diligence on client assets for both buy and sell sides, advising on communication strategies and risk management.
Coach and mentor less experienced colleagues in areas of expertise.
Our Offer
A supportive and collaborative environment with opportunities for professional development.
An outstanding opportunity to join a small consultancy and contribute to its growth.
A home-based role with high flexibility.
A competitive salary commensurate with experience.
An excellent bonus scheme.